510(k) K250834

Zimmer Biomet Ceramic Heads (22.2mm diameter) by Zimmer Biomet — Product Code LZO

K250834 is an FDA 510(k) premarket notification submitted by Zimmer Biomet for the device "Zimmer Biomet Ceramic Heads (22.2mm diameter)". The FDA issued a decision of Substantially Equivalent on April 18, 2025. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Zimmer Biomet has at least 4 other 510(k) clearances on record.